Karl Storz-Endoscopy-America, Inc. · Class II · Cleared Aug 17, 2020
| K-number | K201399 |
| Device name | HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head |
| Applicant | Karl Storz-Endoscopy-America, Inc. |
| Product code | OWN |
| Device class | Class II |
| Decision date | Aug 17, 2020 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
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